A user at MYO asked specifically which studies (on the long list in the What is The Sinclair Method? forum) directly tested The Sinclair Method. I posed the question to Dr. Sinclair and this was his reply:


The Finnish trial was specifically designed to test the method (32. Heinälä, P., Alho, H., Kiianmaa, K., Lönnqvist, J., Kuoppasalmi, K., and Sinclair, J.D. (2001). Targeted use of Naltrexone without prior detoxification in the treatment of alcohol dependence: A factorial double-blind placebo-controlled trial. Journal of Clinical Psychopharmacology, 21(3): 287-292. ). It had one group given naltrexone with instructions to use the medication while drinking in a controlled manner - and then in the latter parts to take the medication only when intending to drink. They were told not to drink more than they normally drank, so as to avoid alcohol poisoning. They also had strong instructions to avoid drinking and driving or using other mechanical equipment. There was a double-blind placebo-controlled group that had the same instructions but received placebo rather than naltrexone. The naltrexone + drinking group did significantly better than the placebo + drinking group. This was a huge difference, partly because the placebo + drinking group did so poorly. This supports not only the conclusion that naltrexone + drinking is safe and effective, but also confirms the conclusion from AA and elsewhere that controlled drinking is not a good solution for alcoholics who are not taking naltrexone.

At the same time, the trial had two other groups. One had naltrexone plus instructions to abstain, and the other one had placebo plus instructions to abstain. Again the groups were randomly assigned and double-blind. The results showed clearly that naltrexone was no effective when used with support of abstinence. Indeed, there was a strong tendency for the naltrexone with support of abstinence to do worse than the placebo plus support of abstinence. Our later work indicates that is because these patients often stop taking naltrexone at the same time start drinking again, thus getting no extinction (since drinking is never paired with naltrexone) but instead supersensitivity-enhanced reinforcement of alcohol drinking.

The naltrexone + drinking group also did significantly better than the naltrexone plus support of abstinence. Thus the conclusion is supported that if you are going to administer naltrexone, it should be done along with instructions to drink normally.

The original Yale study used a similar design although it was not intended to test extinction.(3.O’Malley, S.S., Jaffe, A.J., Chang, G., Schottenfeld, R.S., Meyer, R.E., and Rounsaville, B. (1992). Naltrexone and coping skills therapy for alcohol dependence. Archives of General Psychiatry 49: 881‑887 ). It had the two groups with support of abstinence, and like Heinälä et al found no significant benefits of naltrexone over placebo when abstinence was demanded. It was, however, accidental that they had patients drinking while on naltrexone. Their other two groups were called "Coping" with drinking. They were told that we know you probably will not abstain, but when you do drink, don't lose your confidence and drop out - instead you should cope with drinking. It was admitted by the authors that these instructions did in fact encourage sampling of alcohol. Like Heinälä at al, the naltrexone + coping with drinking did very well, and significantly better than either the placebo + coping with drinking or the naltrexone + support of abstinence.

The Swedish clinical trial used almost the same design and also found the same results. (25. Balldin, J., Berglund, M., Borg, S., Månsson, M., Berndtsen, P., Franck, J., Gustafsson, L., Halldin, J., Hollstedt, C., Nilsson, L-H., and Stolt, G.. (1997) A randomized 6 month double-blind placebo-controlled study of Naltrexone and coping skills education programme. Alcohol and Alcoholism 32: 325 )

The Texas study on naltrexone for cocaine addiction used the same design and found the same results. (59. Schmitz, J. M., Stotts, A. L., Rhoades, H. M., and Grabowski, J. (2001) Naltrexone and relapse prevention treatment for cocaine-dependent patients. Addictive Behavior 26(2):167-180. )

The very first trial found that naltrexone was more effective than placebo in treating heroin addiction in those patients who self-administered heroin while on the medication but not in addicts who abstained from opiates while on the medication (Renault, P. F. (1978) Treatment of heroin-dependent persons with antagonists: Current status. Bulletin on Narcotics 30: 21-29 ). It concluded that extinction was the cause for the benefits.

In addition, we did several dozen experiments with rats demonstrating that naltrexone and other opioid antagonists extinguish alcohol drinking.

David Sinclair

I would be happy to post the annotated bibliography describing the science supporting the Sinclair Method even though it may be somewhat technical. Any takers? (This is reprinted in the appendix to The Cure for Alcoholism.) RDE

Of course we would welcome your posting that appendix. Thanks so much for your input on this site.

Dr. Eskapa - it's already there! I posted the document Dr. Sinclair sent me. It's under the Science Behind the Cure section of the board. Thanks for the offer, though! Feel free to post any other information you run across!